The analysis

Access to medicines: reduced time for patients thanks to Aifa's new portal

Focus on the 'Price and Reimbursement' process seen through the lens of the procedures accelerated by the 'Find Drug Regulations' put in place by the Agency: a 30-day reduction in the waiting time for a medicine to become commercially available is plausible

by Claudio Jommi *, Giovanni Ravasio **

19 February 2026

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5' min read

Translated by AI

Versione italiana

5' min read

Translated by AI

Versione italiana

The evaluation of medicines for the purposes of reimbursement decisions by the National Health Service is a complex activity that requires skilled resources and time. Therefore, analyses investigating the timing of the Pricing and Reimbursement (P&R) processes - a critical factor in patients' access to new therapies - provide a stimulus to assess areas for improvement, both on strictly procedural and evaluative aspects.

L’analisi

The objective of the analysis that we conducted was to evaluate - within the P&R process - the timing of the 'BoD-publication in the Official Gazette' phase, i.e. from the resolution of the Board of Directors of the Italian Medicines Agency (Aifa) concerning the approval of medicinal products for the purposes of Marketing Authorisation and reimbursability by the NHS, to the publication of the related determination (from April 2025) only on the 'Find Medicines Regulations' (Tnf) portal with notice in the Official Gazette. Analysis relating to the period April-December 2025 (data available in the Tnf), also in order to assess the possible reduction in the timing of this phase compared to the "Aifa Report 2018-2022", which had highlighted a non-negligible incidence (on average 28% for all drugs) on the overall timing of the process.

This is a preliminary in-depth study of the Tnf tool: further analyses on other phases of the P&R process will be studied in the light of the information available in the portal and entered into the specially structured database, allowing for ongoing evaluations.

Reimbursement and access times at EU level

In the latest Report 'Efpia Patients Wait (Waiting to Access Innovative Therapies) Indicator Survey'- IQVIA published, relating to the four-year period 2020-2023, Italia is confirmed - among the five most populated European nations - at the top for the number of new reimbursed drugs: with 143 drugs, after Germany (156), before Spain (123), England (113) and France (103). Also with regard to the 'time to access reimbursement' - i.e. the time between EU approval and completion of the evaluation and negotiation processes of the price and reimbursement conditions at national level - our country (with 439 days) is below the EU average (578 days): after Germany (128 days) and England (411 days), ahead of France (570 days) and Spain (616 days). It should be borne in mind that Germany's timeframes are those needed to approve marketing, since the drugs are reimbursed at the price freely determined by the companies, with subsequent negotiation (within 12 months) of discounts and confirmation of reimbursability.

Times in Italia

In addition to the European comparison, it is interesting to know the timing of the various stages that determine the 'time to reimbursement' in our NHS. One of the latest and most complete analyses on the subject is contained in the 'Aifa Report on the timing of drug pricing and reimbursement procedures 2018-2022' (published in April 2023). The report highlights 3 phases under Aifa's responsibility: 'Administrative verification', i.e. the timing between the submission of the P&R application and Aifa's administrative check; 'Entire procedure', represented by the technical and P&R evaluation, a process that ends, in the case of a contracted procedure, with the Board of Directors' decision on reimbursability. Finally, the phase defined as 'Transmission in the Official Gazette of the Italian Republic' corresponding to the 'BoD-publication in the Official Gazette' phase of this analysis.

This phase in detail provides for: drafting of the determination, control and acceptance by the pharmaceutical company, possible testing of the monitoring register, signing of the determination. In addition, it envisaged the transmission of the Aifa determination to the Istituto Poligrafico e Zecca dello Stato for its publication in the Gazzetta (with variable times depending on the amount of provisions to be published): this last step was simplified with the Finding of Medicines Regulations, as described below. The report in the period 2018-2022 had shown long timescales for this phase: on average 64.3 days for generics/biosimilars; 69.6 days for other types of negotiation; 66.1 days for all drugs, with a non-negligible incidence on the overall timescales of the P&R process: 40%, 20% and 28% respectively.

The 'Find Drug Regulations' portal

The Aifa portal, set up in collaboration with the Istituto Poligrafico e Zecca dello Stato, aims to centralise and facilitate the search for acts and measures, allowing users to consult the most recent decisions: the AICs and their secondary amendments, classification and reimbursability determinations for medicines, those extending reimbursable indications, renegotiation of prices and reimbursability conditions, and updates to treatment notes and plans.

After a trial period, the Tnf officially went live on 2 April 2025, allowing consultation of the full text of Aifa's determinations, the legal cognizability of which is guaranteed by the concomitant transmission to the Official Gazette of the relevant notice with the details of the measure: the measure takes effect on the day following the publication of the notice in the Official Gazette.

The aim of this contribution - as a preliminary evaluation of the Tnf tool - was to analyse, in the period April-December 2025, the 'BoD-publication in OJ' timeframe compared to the data of the Aifa Report 2018-2022 and to assess whether the timeframe could be reduced.

Analysis and Results

With reference to the information in the Tnf, it was possible to structure a database in Excel.

In the reporting period (April-December 2025), 665 Aifa determinations were published. On the basis of the exclusion criteria (e.g. date of the BoD absent; corrections, additions, update notes, etc.) 162 determinations were eliminated; therefore, the analysis focused on the remaining 503. The analysis calculated the average and median time elapsed in the 'BoD-publication in OJ' phase and compared with the data in the Aifa Report 2018-2022:

- Average time: reduced from 66 to 45 days (-32%)

- Median time: reduced from 46 to 37 days (-20%)

The results confirm that the introduction of the new approach to the publication of determinations through the Tnf system represents an important procedural innovation implemented by Aifa, which makes it possible to significantly compress the time of this phase. The positive assessment, despite some methodological constraints that make the comparison partially asymmetrical, is further corroborated by the monthly trend: net of seasonal fluctuations linked to holiday periods, a progressive and constant reduction in time is observed. It is therefore reasonable to assume that the goal of a stabilised time frame of around 30 days is achievable.

Further reductions are difficult to envisage due to physiological technical timeframes, linked to activities such as the formal drafting of the determination, its sending for checking and acceptance by the company (a phase in which the adoption of a monitoring register for acceptance is crucial), and the editorial scheduling of notices in the OJ.

Although it is evident that the step analysed represents a minor area of relevance in the overall drug evaluation process, it was deemed interesting to carry out a preliminary in-depth study of the 'Find Drug Standards' tool, in light of the lack of evidence on the subject and the novelty of the topic.

Further analyses on the timing of other phases of the P&R process (e.g. 'whole process') will be studied in the light of the information available in the portal and entered into the specially structured database, allowing for ongoing evaluations.

* Department of Pharmaceutical Sciences, University of Eastern Piedmont, Novara** Health Economics